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Lens Care Solution Is Faulted

An outbreak of fungal infections linked to ReNu With MoistureLoc has raised some questions about the safety of all-in-one lens solutions.Credit
Adam Rountree/Bloomberg News

Federal disease control experts and leading eye doctors have formally concluded that ReNu With MoistureLoc from Bausch & Lomb was the only contact lens solution contributing to an outbreak of potentially blinding fungal eye infections earlier this year.

But the researchers’ report, to be published today in The Journal of the American Medical Association, says it remains unclear how the product caused the problems.

An accompanying commentary by two academic researchers, meanwhile, argues that further study is needed to gauge the safety of various brands of “multipurpose” lens care solutions on the market that, like MoistureLoc, are used for cleaning, storing and moistening soft contact lenses.

The research report challenged Bausch & Lomb’s argument that a major factor in the outbreak was customers’ failure to properly clean their lenses and regularly replace the storage solution.

“Practicing good contact lens hygiene is a prudent and common-sense measure for all contact lens wearers, irrespective of contact lens solution used,” Dr. Douglas C. Chang, a fungal disease specialist at the Centers for Disease Control, who was lead author on the report, said in an e-mail interview. “However, the most important message for contact lens wearers is to stop using MoistureLoc, and throw out any MoistureLoc solution purchased before the recall.”

The infections showed up in Asia last year and peaked in the United States this spring, shortly after Bausch withdrew MoistureLoc from the domestic market on April 13. Bausch announced a worldwide recall a month later. The events caused the company’s stock and profit forecasts to plunge.

In some ways, the journal article is mildly positive news for Bausch, saying the number of confirmed new infection cases has slowed to a trickle since the recall.

The analysis also found no evidence of unusual risks with an older Bausch product, ReNu MultiPlus, which the company has pushed as a replacement for MoistureLoc. Since the recall, the company has been counting on renewed growth from MultiPlus to rebuild its formerly lucrative lens care business.

The company expressed satisfaction with the article.

“We think the report confirms that Bausch & Lomb took the right action in the interests of consumer health and safety by recalling the MoistureLoc product, and that Bausch & Lomb can continue to recommend its ReNu MultiPlus solution with confidence,” the company said in an e-mail response to questions about the report.

The medical journal data analysis was based on 164 confirmed cases of Fusarium fungus eye infections in the United States from the beginning of June 2005 to the end of June this year. The analysis concluded that just over one-third of the patients had suffered serious enough damage to one or both eyes to require corneal transplants.

Before the withdrawal, about 2.3 million of the nation’s 30 million soft lens wearers used MoistureLoc. The analysis did not say how many of the most seriously injured patients used MoistureLoc, but the product was used by a large majority of those reporting fungal infections.

The researchers did find some evidence for the company’s contention that topping off lens care solution in contact lens storage cases instead of replacing the solution raised the risk of fungal infection. But they said that in other respects there was no difference between the practices of the people infected and those who remained healthy.

The study showed just one confirmed infection in June, and Dr. Chang said last week that health care officials had “every indication that the outbreak was over.”

But, he said, health authorities continue to hear sporadic, unconfirmed reports of infections that appear related to use of MoistureLoc supplies purchased before the recall.

Bausch is a long way from putting the debacle behind it.

Two weeks ago, the company said in a filing with the Securities and Exchange Commission that pretax profits this year would fall to $80 million or less, a 78 percent drop from last year and far below Wall Street’s estimates. The expenses of the recall and efforts to rebuild market share are also forecast to hurt earnings and sales in 2007.

The company is also facing numerous consumer lawsuits linked to the outbreaks.

Bausch’s shares closed yesterday at $46.39, down 3 cents. Fusarium, typically found in tropical countries, is a widely distributed family of fungi. In the past, the most common victims of Fusarium infections have been agricultural workers or others in rural areas who scratch an eye with a twig or some other plant harboring the fungus.

The potential link between Bausch’s products and Fusarium infections was first reported in Asia last year when health authorities in Singapore and Hong Kong noticed a surge in infections among wearers of soft contact lenses.

MoistureLoc, which Bausch first introduced in the fall of 2004, was removed from several Asian markets in February this year. Bausch began receiving reports of cases in the United States in March, including some among lens users in northern states where Fusarium infections are extremely rare.

Bausch eventually concluded that MoistureLoc’s formulation could create biofilms in some circumstances that would shield the fungus from the sterilizing agent in MoistureLoc. That could allow Fusarium to colonize a lens case or bottle cap, the company said.

In May, Dr. Daniel G. Schultz, the director of the Food and Drug Administration Center for Devices and Radiological Health, said that the agency was “reasonably certain” that Bausch had provided a “good answer” to what had gone wrong. But the authors of the journal report said there was too little evidence to identify the exact problem with MoistureLoc and that more research was needed.

In the accompanying commentary, Dr. Todd P. Margolis and Dr. John P. Whitcher of the Proctor Foundation for Research in Ophthalmology at the University of California, San Francisco, called for more rigorous study of the entire class of all-in-one lens care products.

While the simplicity of multipurpose solutions appeals to consumers, some doctors fear the solutions make it harder to reliably sterilize lenses than systems that use a separate cleaning agent.

Dr. Margolis said in an interview that there was some evidence that the number of Fusarium cases began to rise before MoistureLoc was first marketed.

“There are many cases out there that haven’t been fully investigated,” he said.

The commentary also called for more research on the best antimicrobial agents to treat fungal eye infections, which are far rarer than bacterial eye infections but are still a major cause of blindness in developing countries.

They noted that in 25 percent of the Fusarium cases reviewed in a prominent ophthalmology journal earlier this year, doctors had at first mistakenly prescribed an anti-inflammatory treatment that is appropriate for bacterial infections but actually makes fungal infections worse.